FDA asks doctors to limit acetaminophen in combination drugs

(Reuters) - U.S. health regulators recommended on Tuesday
that healthcare professionals stop prescribing combination drugs
that contain more than 325 milligrams of acetaminophen per
tablet, capsule or other dosage unit, citing the risk of liver
damage.

Limiting the quantity per dosage unit will reduce the risk
of inadvertent overdose, which can lead to liver failure, liver
transplant and death, the Food and Drug Administration said. It
cited the fact that no available data showed that taking more
than the recommended dose provided benefits that outweighed the
added risks.

Inadvertent overdose from combination drugs containing
acetaminophen, also known as paracetamol in most countries
outside the United States, accounts for nearly half of all cases
of acetaminophen-related liver failure in the United States, the
agency said.

In January 2011, the FDA asked manufacturers of combination
drugs containing acetaminophen, sold globally under trade names
such as Tylenol and Panadol, to limit acetaminophen doses to no
more than 325 mg in each tablet or capsule by January 14, 2014.

Some of these products still remain available, the agency
said.

The FDA also suggested that pharmacists who receive a
prescription for a combination product with more than the
recommended dose contact the prescriber to discuss using a lower
dose.

In the near future, the FDA plans to institute proceedings
to withdraw approval for combination drugs that remain on the
market, it said in a statement.

Acetaminophen, one of the most commonly used drugs in the
United States, is widely used in both prescription and
over-the-counter products to reduce pain and fever.